The present invention relates to a heartburn and reflux disease treatment apparatus and method. More specifically, the invention relates to a heartburn and reflux disease treatment apparatus and method for surgical application in the abdomen of a patient for forming a restricted food passageway in the esophagus or stomach. The term xe2x80x9cpatientxe2x80x9d includes an animal or a human being.
Chronic heartburn and reflux disease is a widespread medical problem. This is often due to hiatal hernia, i.e. a portion of the stomach immediately below the gastric fundus slides upwardly through the esophageal hiatus. In consequence, stomach acids and foods are regurgitated into the esophagus.
In the late 1970s a prior art prosthesis called Angelchik, according to U.S. Pat. No. 3,875,928, was used to operatively treat heartburn and reflux disease. However, the Angelchik prosthesis had a major disadvantage in that it was not possible to adjust the size of the restriction opening after the operation. A further disadvantage was that the prosthesis did not satisfactorily protect the esophagus and the surrounding area against injuries due to poor shape of the prosthesis. Moreover, the prosthesis was sutured to the stomach, in order to be properly positioned. Such a suture arrangement, however, is not reliable. Therefore, operations using the Angelchik prosthesis are no longer practiced.
An operation technique, semi-fundoduplicatio, is currently in use for treating heartburn and reflux disease. A most common operation is Nissen semi-fundoduplicatio, in which one takes the fundus of the stomach and makes a three quarter of a turn around the esophagus and suture between the stomach and esophagus. Although this operation works fairly well it has three main disadvantages. Firstly, most patients treated in accordance to xe2x80x9cad modum Nissenxe2x80x9d lose their ability to belch. Secondly, many of these patients get dysphagia, i.e. have difficulties in swallowing after the operation. Thirdly, it is not possible to adjust the food passageway in the esophagus or stomach in any way after the operation. Characteristic for these patients is the variation of their problems over the course of a day. For example, many patients have difficulties during the night when they lie down because of stomach acid leaking up into the esophagus.
The object of the present invention is to provide a new heartburn and reflux disease treatment apparatus which permits post-operation adjustments.
Accordingly, the present invention provides a heartburn and reflux disease treatment apparatus comprising an adjustable restriction device implanted in the patient and engaging the stomach close to the cardia or engaging the esophagus to form a restricted food passageway in the stomach or esophagus, an adjustment device implanted in the patient for adjusting the restriction device to restrict and enlarge the food passageway, and a hydraulic operation device implanted in the patient for operating the adjustment device. As a result, the restriction device works like an artificial sphincter, which can be adjusted by the patient in connection with every food intake during the day, or possibly only in the morning to open up the food passageway and in the evening to close the food passageway.
Preferably the restriction device is powered and controlled in a non-manual manner. The expression xe2x80x9cnon-manually mannerxe2x80x9d should be understood to mean that the restriction device is not adjusted by manually touching subcutaneously implanted components of the apparatus or not manipulated by touching the skin of the patient. Preferably, the adjustment device adjusts the restriction device in a non-invasive manner. The expression powered should be understood as energized with everything without manual force, preferably electric energy.
The adjustment device may adjust the restriction device in a non-magnetic manner, i.e. magnetic forces may not be involved when adjusting the restriction device.
The adjustment device may also adjust the restriction device in a non-thermal manner, i.e. thermal energy may not be involved when adjusting the restriction device.
Generally the implanted restriction device comprises a holding device for preventing the region of the cardia to pass through the esophageal hiatus diaphragmatica. This could be achieved by an enlarged area of the esophagus and/or the restriction device that prevents the esophagus from passing the hole in the diaphragmatic muscle where the esophagus passes (a triangular opening surrounded by the crus muscles) or by fixing or holding the region of the cardia in place. The holding device may take the shape of a support member that provides a support for the restriction device upwardly against the diaphragm muscle. Alternatively, the holding device may comprise sutures, or the restriction device itself could be shaped to prevent the region of the cardia from sliding up. It would also be possible to provide means for narrowing the triangular opening.
In the various embodiments hereinafter described the restriction device generally forms an at least substantially closed loop. However, the restriction device may take a variety of different shapes, such as the shape of a square, rectangle or ellipse. The substantially closed loop could for example be totally flat, i.e. thin as seen in the radial direction. The shape of the restriction device may also be changed during use, be rotated or turned or moved in any direction. A physical lumen, such as the passageway in the esophagus, often is easier to restrict by contracting two opposite side walls of the lumen against each other. Thus, the restriction device may be designed to perform such a contracting effect of the opposite walls of the esophagus. Either mechanical or hydraulic solutions may be employed to operate the restriction device. Alternatively, the restriction device may comprise an adjustable cuff, a clamp or a roller for bending or rotating the esophagus or stomach to close or almost close its passageway. Such a cuff, clamp or roller may also be utilized for squeezing the esophagus against human material inside the body of the patient or against implanted structures of the apparatus. The bending or rotating members may have any shape or form and be either hydraulic or non-inflatable.
In accordance with a first main embodiment of the invention, the adjustment device comprises an expandable cavity in the restriction device, wherein the food passageway is restricted upon expansion of the cavity and enlarged upon contraction of the cavity. The cavity may change shape or form to restrict the food passageway.
The hydraulic operation device may comprise an injection port implanted subcutaneously in the patient for transcutaneously adding fluid to and withdrawing fluid from the cavity for accomplishing necessary post-operation adjustments of the restriction device to restrict or enlarge the food passageway in the esophagus or stomach. It is preferred, however, that the apparatus of the invention further comprises a reservoir implanted in the patient and containing a predetermined amount of hydraulic fluid, wherein the hydraulic operation device operates the adjustment device by using the hydraulic fluid of the reservoir. For example, the operation device may distribute hydraulic fluid from the reservoir to expand the cavity, and distribute hydraulic fluid from the cavity to the reservoir to contract the cavity, to thereby control the restriction of the passageway. As a result, there is no need for an injection port. (In certain applications, however, an injection port connected to the reservoir may be provided for enabling, normally a single once-and-for-all, calibration of the predetermined amount of fluid in the reservoir. In this case, the injection port suitably is integrated in the reservoir.)
A fluid distribution tube may readily be connected between the reservoir and the cavity in a manner so that the tube does not interfere with other implanted components of the apparatus.
Preferably, the reservoir defines a chamber for the predetermined amount of fluid and the hydraulic operation device changes the size of the chamber. The hydraulic operation device suitably comprises first and second wall portions of the reservoir, which are displaceable relative to each other to change the size of the chamber of the reservoir. The hydraulic operation device may distribute fluid from the reservoir to the cavity of the restriction member in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir and may distribute fluid from the cavity to the reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion.
The first and second wall portions of the reservoir may be displaceable relative to each other by manual manipulation, such as by manually pushing, pulling or rotating any of the wall portions in one direction, or alternatively, may be displaceable relative to each other by a device powered magnetically, hydraulically, or electrically (e.g. by an electric motor). In this embodiment no pump is used, only the volume of the reservoir is varied. This is of great advantage compared to the solution described below when a pump is used to pump fluid between the reservoir and the adjustment device because there is no need for a non-return valve and it is still possible to have fluid flowing both to and from the reservoir.
In accordance with a particular embodiment of the invention, the hydraulic operation, device comprises an activatable pump for pumping fluid between the reservoir and the cavity of the restriction device. The pump preferably comprises a first activation member for activating the pump to pump fluid from the reservoir to the cavity of the restriction device, and a second activation member for activating the pump to pump fluid from the cavity to the reservoir. The first and second activation members may be operable by manual manipulation thereof, such as by manually pushing, pulling or rotating any of the activation members in one direction. At least one of the activation members is constructed to operate when subjected to a predetermined external pressure.
As an alternative to the manual manipulation, at least one of the first and second activating members may be operable by a device powered magnetically, hydraulically, or electrically (e.g. by an electric motor). The pump may pump fluid both to and away from the adjustment device or hydraulic device controlling the adjustment device. A mechanical solution is proposed in which it is possible to pump in both directions just by pushing an activating member in one direction. Another alternative is a pump pumping in only one direction and an adjustable valve to change the direction of fluid to either increase or decrease the amount of fluid in the reservoir. This valve may be manipulated either manually, mechanically, magnetically, or hydraulically. Any kind of motor could be used for the different operations as well as wireless remote solutions.
Wherever a magnetic means is utilized according to the invention it may comprise a permanent magnet and a magnetic material reed switch, or other suitable known or conventional magnetic devices.
In accordance with a second main embodiment of the invention, the restriction device comprises an elongated restriction member and forming means for forming the restriction member into at least a substantially closed loop around the esophagus or stomach, the loop defining a restriction opening, whereby the adjustment device adjusts the restriction member in the loop to change the size of the restriction opening.
Advantageously, the forming means may form the restriction member into a loop having a predetermined size.
The adjustment device may change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member either is changed or is unchanged.
In accordance with an embodiment of the invention, the elongated restriction member is non-inflatable and flexible, and the adjustment device pulls a first portion of the flexible restriction member from a second portion of the flexible restriction member opposite the first portion in the loop to squeeze the esophagus or stomach between two opposite lengths of the elongated flexible restriction member to restrict the passageway and releases the esophagus or stomach from the flexible restriction member to enlarge the passageway.
In accordance with a third main embodiment of the invention, the adjustment device mechanically adjusts the restriction device. Thus, the restriction device may comprise at least two elements on different sides of the esophagus or stomach, and the adjustment device may restrict the esophagus or stomach between the elements to restrict the passageway and may release the esophagus or stomach from the elements to enlarge the passageway. It is also possible to use only one element and restrict against human bone or tissue.
In accordance with an alternative, the restriction device may comprise two articulated clamping elements positioned on opposite sides of the esophagus or stomach, and the adjustment device may move the clamping elements toward each other to clamp the esophagus or stomach between the clamping elements to restrict the passageway, and may move the clamping elements away from each other to release the esophagus or stomach from the elements to enlarge the passageway.
In accordance with another alternative, the restriction device may bend a portion of the esophagus or stomach. For example, the restriction device may comprise at least two bending members, such as cylindrical or hour-glass shaped rollers, positioned on opposite or different sides of the esophagus or stomach and displaced relative to each other along the food passageway in the esophagus or stomach. The adjustment device may move the bending members against the esophagus or stomach to bend the latter to restrict the passageway, and away from the esophagus or stomach to release them from the bending members to enlarge the passageway. The bending members may have any shape or form and be both hydraulic or non-inflatable.
In accordance with another alternative aspect of the present invention there is provided two holding members, one placed more distal than the other, forming at least two substantially closed loops which may be rotated in opposite directions to each other. With interconnecting means for example flexible bands between the holding members a restriction will occur between the holding members when they are rotated.
The restriction device may in all applicable embodiments have any shape or form and be either hydraulic or non-inflatable.
In accordance with another particular embodiment of the invention, the hydraulic operation device comprises a servo means, suitably including hydraulic means. Alternatively, the servo means may include magnetic or electric means. Preferably, the servo means comprises a servo reservoir defining a chamber containing servo fluid and the hydraulic operation device comprises first and second wall portions of the servo reservoir, which are displaceable relative to each other to change the size of the chamber of the servo reservoir. The same principle will apply for the servo reservoir as for the earlier described reservoir wherein the volume in the servo reservoir may be increased or decreased by a first or second displacement of the first wall portion relative to the second wall portion of the servo reservoir and thereby control the earlier described reservoir and thereby indirectly control the cross-sectional area of the food passageway. The first and second wall portions of the servo reservoir may be displaceable relative to each other by manual manipulation, such as by manually pushing, pulling or rotating any of the wall portions of the servo reservoir in one direction. Alternatively, the first and second wall portions may be displaceable by magnetically, hydraulically or electrically powered devices. These powered devices may all be activated by manual manipulating means preferably located subcutaneously. This activation may be indirect, for example via a switch.
Especially when manual manipulation means are used, the servo means is suitable to use. With servo means less force is needed for controlling the adjustment device. Hydraulic operation is preferably used with the servo means. One example is a closed system that controls another closed system in which hydraulic components of the adjustment device are incorporated. Minor changes in the amount of fluid in a reservoir of the first system could then lead to major changes in the amount of fluid in a reservoir in the second system. Consequently, the change in volume in the reservoir of the second system affects the hydraulic operation of the adjustment device which is incorporated in the second closed system. The great advantage of such a servo means is that the larger volume system could be placed at a suitable location, e.g. inside the abdomen where there is more space, and still it would be possible to use manual manipulation means of the smaller system subcutaneously. The servo reservoir could control the reservoir of the larger volume.
The servo reservoir could be controlled directly or indirectly by a small fluid supply reservoir, which may be placed subcutaneously and may be activated by manual manipulation means controlling the servo reservoir or other suitable device.
Preferably, the hydraulic operation device comprises first and second wall portions of the fluid supply reservoir, which are displaceable relative to each other to change the size of the chamber of the fluid supply reservoir. The hydraulic operation device may distribute fluid from the fluid supply reservoir to the servo reservoir in response to a predetermined first displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir and to distribute fluid from the servo reservoir to the fluid supply reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion. The wall portions of the fluid supply reservoir may be displaceable relative to each other by manual manipulation means or be displaceable relative to each other by manual manipulation means for pushing, pulling, or rotating any of the wall portions of the fluid supply reservoir in one direction. Alternatively, the wall portions of the fluid supply reservoir may be displaceable relative to each other by magnetic means, hydraulic means, manually manipulated means, or electrical control means including an electric motor. The magnetic means, hydraulic means, or electrical control means may all be activated by manually manipulated means preferably located subcutaneously. This control may be indirect, for example via a switch.
Even in the broadest embodiment of the invention the adjustment device may comprise a servo means. The servo means may comprise a hydraulic means, an electric control means, a magnetic means, mechanical means, or a manual manipulating means. The hydraulic means, electric control means, mechanical means or magnetic means may be activated by manual manipulating means. Using a servo system will save the use of force when adjusting the adjustment device which may be of importance in many applications.
The hydraulic fluid used by the operation device in any of the above embodiments may be of a kind that changes viscosity when it is exposed to energy different from thermal energy. For example, the viscosity of the hydraulic fluid may change when the fluid is exposed to electric energy. It should be understood that the word fluid also could incorporate gas or air in all embodiments.
All systems according to the invention may be controlled by a wireless remote control.
In accordance with an advantageous embodiment of the invention, there is provided a wireless remote control for non-invasively controlling the hydraulic operation device. The remote control may advantageously be capable of obtaining information on implanted components of the apparatus, in particular related to the food passageway, and of commanding the hydraulic operation device to operate the adjustment device to adjust the restriction device in response to obtained information.
The remote control comprises means for wireless transfer of energy from outside the human""s or animal""s body to energy consuming implanted components of the apparatus. A motor may suitably be implanted for operating the hydraulic operation device and the means for wireless transfer of energy may directly power the motor with transferred energy. The energy transferred by the means for transfer of energy may comprise wave signals, an electric field or a magnetic field.
The wireless remote control comprises an external signal transmitter, receiver or transceiver and an implanted signal receiver, transmitter or transceiver. For example, the external signal transmitter and implanted signal receiver may transmit and receive a signal in the form of digital pulses, which may comprise a magnetic or electric field. Alternatively, which is preferred, the signal transmitter and signal receiver may transmit and receive a signal, which comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for remote control signals. The receiver may comprise a control unit for controlling the hydraulic operation device in response to a control signal from the signal transmitter.
The apparatus of the invention may further comprise an implanted energizer unit for providing energy to implanted energy consuming components of the apparatus, such as electronic circuits and/or a motor for operating the hydraulic operation device. The control unit may power such an implanted motor with energy provided by the energizer unit in response to a control signal received from the external signal transmitter. Any known or conventional signal transmitting or signal receiving device that is suitable for use with a human or mammal patient may be provided as the external signal transmitter or implanted signal receiver. The control signal may comprise an electromagnetic wave signal, such as an infrared light signal, a visible light signal, a laser light signal, a microwave signal, or a sound wave signal, such as an ultrasonic wave signal or an infrasonic wave signal, or any other type of wave signals. The control signal may also comprise electric or magnetic fields, or pulses. All of the above-mentioned signals may comprise digital signals. The control signal may be carried by a carrier signal, which may be the same as the wireless energy signal. Preferably, a digital control signal may be carried by an electromagnetic wave signal. The carrier signal or control signal may be amplitude or frequency modulated.
The motor may be any type of motor, such as a pneumatic, hydraulic or electric motor and the energizer unit may power the motor with pressurized gas or liquid, or electric energy, depending on the type of motor. Where the motor is an electric motor, it may power pneumatic or hydraulic equipment.
The energizer unit may comprise a power supply and the control unit may power the motor with energy from the power supply. Preferably, the power supply is an electric power supply, such as a battery, and the motor is an electric motor. In this case, the battery also continuously powers the circuitry of the signal receiver between the adjustment operations, in order to keep the signal receiver prepared for receiving a signal transmitted from the signal transmitter.
The energizer unit may transfer energy from the control signal, as the latter is transmitted to the signal receiver, into electric energy for powering the implanted electronic components. For example, the energizer unit may transfer the energy from the control signal into direct or alternating current.
In case there is an implanted electric motor for operating the hydraulic operation device the energizer unit may also power the motor with the transferred energy. Advantageously, the control unit directly powers the electric motor with electric energy, as the energizer unit transfers the signal energy into the electric energy. This embodiment is particularly simple and does not require any recurrent invasive measures for exchanging empty power supplies, such as batteries, that is required in the first embodiment described above.
For adjustment devices of the type that requires more, but still relatively low, power for its operation, the energizer unit may comprise a rechargeable electric power supply for storing the electric energy obtained and the control unit may power the electric motor with energy from the rechargeable electric power supply in response to a control signal received from the signal transmitter. In an initial charging step the rechargeable power supply can be charged over a relatively long time (e.g. a few seconds up to a half hour) without powering the electric motor. In a following operating step, when the power supply has been charged with sufficient energy, the control unit powers the electric motor with energy from the charged power supply to operate the hydraulic operation device, so that a desired change of the cross-sectional area of the food passageway is achieved. If the capacity of the power supply is insignificant to achieve the necessary adjustment in one single operating step, the above steps may conveniently be repeated until the desired adjustment is achieved.
The electric power supply suitably comprises an inexpensive simple capacitor. In this case, the electric motor may be a stepping motor.
The signal transmitter may transmit an electromagnetic control signal and the energizer unit may draw radiant energy from the electromagnetic wave signal, as the latter is transmitted to the signal receiver, and may transfer the radiant energy into electric energy. Alternatively, the energizer unit may comprise a battery, an electrically operable switch for connecting the battery to the signal receiver in an on mode when the switch is powered and for keeping the battery disconnected from the signal receiver in a standby mode when the switch is unpowered, and a rechargeable electric power supply for powering the switch. The control unit may power the electric motor with energy from the battery in response to a control signal received from the signal transmitter, when the switch is in its on mode. Advantageously, the energizer unit may transfer wave energy from the control signal, as the latter is transmitted to the signal receiver, into a current for charging the rechargeable electric power supply, which suitably is a capacitor. Energy from the power supply is then used to change the switch from off (standby mode) to on. This embodiment is suited for adjustment devices of the type that require relatively high power for their operation and has the advantage that the electronic circuitry of the signal receiver does not have to be powered by the battery between adjustment operations. As a result, the life-time of the battery can be significantly prolonged. The switch may also be mechanically, manually or magnetically operated. Preferable the switch is controlled by wireless energy.
As an example, the signal transmitter may transmit an electromagnetic wave signal and the energizer unit may draw radiant energy from the electromagnetic wave signal, as the latter is transmitted to the signal receiver, and may transfer the radiant energy into electric current. The energizer unit suitably comprises a coil of the signal receiver for inducing an alternating current as the electromagnetic wave signal is transmitted through the coil and a rectifier for rectifying the alternating current. The rectified current is used for charging the rechargeable power source.
Alternatively, the signal transmitter and receiver may solely be used for control signals and a further signal transmitter and signal receiver may be provided for transferring signal energy to implanted components. By such a double system of signal transmitters and receivers the advantage is obtained that the two systems can be designed optimally for their respective purposes, namely to transmit control signals and to transfer energy from signals.
A control device for controlling the restriction device may conveniently be provided and may comprise an internal programmable control unit implanted in the patient and, possibly an external control unit outside the patient""s body for programming the programmable internal control unit. Alternatively, the external control unit may be programmable and wirelessly control the restriction device. At least one sensor for sensing at least one physical parameter of the patient may conveniently be implanted in the patient. The sensor may sense the pressure against the restriction device or the colon or rectum or other important parameters. Either the internal control unit or the external control unit of the control device may suitably control the restriction device to release the fecal passage way. For safety the restrictor device may release the fecal passageway in response to the sensor sensing for example an abnormally high pressure. The internal control unit may directly controls the restriction device in response. to signals by the sensor.
The apparatus preferably comprises a control device having an internal and/or an external control unit for controlling the restriction device preferably for wirelessly controlling the restriction device. Preferably the implanted internal control unit is programmable by the external control unit. The external control unit may also be programmable.
The adjustment device or other energy consuming components of the apparatus may also be energized with wirelessly transmitted energy from outside the patient""s body or with an implanted battery or accumulator.
The apparatus may further comprise an implanted energy transfer device, wherein the control device releases electric energy and the energy transfer device transfers the electric energy direct or indirect into kinetic energy for operation of the restriction device.
The apparatus according may further comprise a pressure sensor for directly or indirectly sensing the pressure against the restriction device or other important parameters of the patient or the heartburn and reflux disease apparatus and the control device may control the restriction device in response to signals from the pressure sensor. The adjustment device preferably non-invasively adjusts the restriction device to change the size of the cross-sectional area.
In all applications a motor may be operatively connected to the adjustment device. A reversing device may control the motor and may be implanted in the patient for reversing the motor. The reversing device implanted in the patient may also reverse the function performed by the restriction device.
The adjustment device preferably in all embodiments adjusts the restriction device in a non-manual manner.
It should be understood that all the applicable embodiments in this application may be combined to achieve alternative embodiments of the invention.
The above described embodiments according to the general aspect of the invention may also be implemented in the described embodiments according to the alternative aspects of the invention, where applicable.
The invention also relates to a method of treating a human or animal having heartburn and reflux disease, comprising (a) Surgically implanting in the abdomen of the human or animal an adjustable restriction device which restricts a food passageway in the stomach close to the cardia or in the esophagus. And (b) from time to time, adjusting the restriction device so as (i) to enlarge the restricted passageway to allow food to readily pass therethrough into the human""s or animal""s stomach, or to allow the human or animal to regurgitate, or (ii) to restrict the restricted passageway sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus. The restriction device may comprise a cavity which is expandable and contractable by the supply of hydraulic fluid thereto, wherein (a) is practiced in part by implanting in the human or animal a reservoir containing a predetermined amount of hydraulic fluid and connecting the reservoir to the cavity and a hydraulic operation device for distributing fluid from the reservoir to the cavity, and wherein (b) is practiced by controlling the hydraulic operation device from a point outside the human""s or animal""s body without physically penetrating the human""s or animal""s body.
In accordance with one alternative, the restriction device may comprises a cavity which is expandable and contractable by the supply of hydraulic fluid thereto, wherein (a) is practiced in part by subcutaneously implanting in the human or animal an injection port connected to the cavity of the restriction device, and wherein (b) is practiced by injecting fluid through the injection port to expand the cavity to restrict the passageway and by withdrawing fluid from the injection port to contract the cavity to enlarge the passageway.
In accordance with another alternative, the restriction device is acted upon by an adjustment device which mechanically adjusts the restriction of the food passageway; wherein (a) is practiced in part by implanting in the human or animal the adjustment device, implanting a reservoir containing a predetermined amount of hydraulic fluid and connecting the reservoir to the cavity, and implanting a hydraulic operation device for distributing fluid from the reservoir to the cavity; and wherein (b) is practiced by controlling the hydraulic operation device from a point outside the human or animal""s body without physically penetrating the human""s or animal""s body to control the adjustment device so that the restriction of the food passageway is changed.
In accordance with yet another alternative, (a) is practiced by: (i) inflating the human""s or animal""s abdomen with gas by penetration of the human""s or animal""s skin, (ii) introducing at least two laparascopic trocars into the abdomen to introduce the restriction device and one or more medical instruments, and then (iii) applying the restriction device on the esophagus or stomach.
The invention also relates to a further method of treating a human or animal having heartburn and reflux disease, comprising (a) Surgically implanting in the abdomen of the human or animal an adjustable restriction device which restricts a food passageway in the stomach close to the cardia or in the esophagus. And (b) from time to time, adjusting the restriction device so as (i) to enlarge the restricted passageway to allow food to readily pass therethrough into the human""s or animal""s stomach, or to allow the human or animal to regurgitate, or (ii) to restrict the restricted passageway sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus.
The invention also relates to yet a further method of treating a human or animal having heartburn and reflux disease, comprising the steps of: (a) Laparascopically placing a restriction device of the apparatus through the abdomen or thorax of a the human or animal. (b) Placing at least two laparoscopic trocars within the human""s or animal""s body. (c) Using a dissecting tool inserted through the laparoscopic trocar, dissecting the region of the esophagus or stomach. (d) Introducing the restriction device through the trocars. (e) Placing the restriction device in engagement with the esophagus or the upper part of the stomach to create a restricted stoma. And (f) from time to time, adjusting the restriction device so as (i) to enlarge the restricted stoma to allow food to readily pass therethrough into the human""s or animal""s stomach, or to allow the human or animal to regurgitate, or (ii) to restrict the restricted stoma sufficiently so as to substantially prevent regurgitation of stomach acids and foods into the esophagus.